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Felodipine 5 Mg Tabs 100 Unit Dose By Mylan

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Felodipine 5 Mg Tabs 100 Unit Dose By Mylan

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Felodipine 5 Mg Tabs 100 Unit Dose By Mylan This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD4076980/RXB10041131
Size : 100
Selling UoM : EA
NDC: 51079-0467-20
UPC Barcode : 351079467202
Supplier: 0050000572 MYLAN INSTITUTIONAL/PGN
Supplier Material : 046720
Generic Code : 016295 FELODIPINE ORAL TAB ER 24H 5 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic RX

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Product Description.:

M, F12
tablet , film-coated , yellow , round round
Debossed

PLENDIL (felodipine) is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ? ethyl methyl 4-(2,3-dichlorophenyl)-1,4- dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate.

Felodipine is a slightly yellowish, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture.

Tablets PLENDIL provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg, or

10 mg of felodipine for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: Tablets PLENDIL 2.5 mg - hydroxypropyl cellulose, lactose, FD&C Blue 2, sodium stearyl fumarate, titanium dioxide, yellow iron oxide, and other ingredients. Tablets PLENDIL 5 mg and 10 mg - cellulose, red and yellow oxide, lactose, polyethylene glycol, sodium stearyl fumarate, titanium dioxide, and other ingredients.

INDICATIONS

PLENDIL is indicated for the treatment of hypertension.

PLENDIL may be used alone or concomitantly with other antihypertensive agents.

SIDE EFFECTS

In controlled studies in the United States and overseas, approximately 3000 patients were treated with felodipine as either the extended-release or the immediate-release formulation.

The most common clinical adverse events reported with PLENDIL administered as monotherapy at the recommended dosage range of 2.5 mg to 10 mg once a day were peripheral edema and headache. Peripheral edema was generally mild, but it was age and dose related and resulted in discontinuation of therapy in about 3% of the enrolled patients. Discontinuation of therapy due to any clinical adverse event occurred in about 6% of the patients receiving PLENDIL, principally for peripheral edema, headache, or flushing.

Adverse events that occurred with an incidence of 1.5% or greater at any of the recommended doses of 2.5 mg to 10 mg once a day (PLENDIL, N = 861 Placebo, N = 334), without regard to causality, are compared to placebo and are listed by dose in the table below. These events are reported from controlled clinical trials with patients who were randomized to a fixed dose of PLENDIL or titrated from an initial dose of 2.5 mg or 5 mg once a day. A dose of 20 mg once a day has been evaluated in some clinical studies. Although the antihypertensive effect of PLENDIL is increased at 20 mg once a day, there is a disproportionate increase in adverse events, especially those associated with vasodilatory effects